A Multicenter Randomized Double-blind Vehicle-controlled Phase 3 Efficacy and Safety Study of Patidegib Topical Gel 2% for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects with Basal Cell Nevus Syndrome

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    Recruiting
  • participants needed
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Updated on 19 February 2024

Summary

Subjects 18 years or older diagnosed with basal cell nevus syndrome (BCNS, also known as Gorlin syndrome). The main purpose of this study is to see if the study gel, which is applied to the face, reduces the number of new surgically eligible BCCs and learn more about the safety of the study gel. This information will be obtained by taking samples blood and urine, collection of medical exams performed by the study doctor, collection of images of facial area, and by taking biopsies (tissue samples) of skin. Key Inclusion criteria: The subject must meet diagnostic criteria for BCNS (Inclusion Criteria 3). The subject must have had at least 10 (with at least 3 on the face) clinically typical BCCs present within 24 months prior to Randomization (Baseline/Day 1). Additionally, the subject must have at least 2 BCCs with longest diameter 5 mm present on the face prior to randomization. The subject must be willing to abstain from application of a non-study topical medication (prescription or over the counter) to facial skin for the duration of the trial.

Details
Condition Basal Cell Carcinomas
Age 99years or below
Clinical Study IdentifierTBD
Last Modified on19 February 2024

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